Fornix and NbM as Targets of Stimulation In Alzheimer's Disease

Alzheimer Disease Clinical Trial

— FANTASIA  

Official title:

A Randomized Controlled Study of 12 Months to Evaluate the Safety and Efficacy of Deep Brain Stimulation(DBS) to the Fornix & Meynert Nucleus(NbM) in Patients With Mild to Moderate Alzheimer's Disease(AD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03352739
• Other study ID #: XuanwuH
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2017
• Last updated: January 10, 2018
• Start date: December 1, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2017
• Source: Xuanwu Hospital, Beijing
• Contact: Guo-Guang Zhao, M.D.
• Phone: +86-010-63037023
• Email: ggzhao[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary goal of this study is to evaluate the efficacy and safety of the DBS to the fornix/NbM among patients who are diagnosed as AD according to a series of evaluations including cerebrospinal fluid (CSF) biomarkers and molecular imaging examinations; The secondary goal is to compare the efficacy among the two treatment groups of different targets.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects with informed consent;

2. 45-75 years of age;

3. At least 6 years of education;

4. AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) guidelines (McKhann et al., 2011);

5. Clinical Dementia Rating Scale (CDR): 1.0-2.0;

6. Positive findings with amyloid PET imaging;

7. Stable prescription of donepezil (5mg, qd) for at least 3 months, and without any intentions to modify the dosage during the observation period.

Exclusion Criteria:

1. Fazekas scale>2;

2. Neuropsychiatric inventory (NPI) total score =10, or any subdomain=4;

3. Modified Hachinski ischemic score>4;

4. Young Mania Rating Scale>11(Young, Biggs, Ziegler, & Meyer, 1978);

5. Any suicidal tendencies in recent 2 years;

6. Cornell Scale for Depression and Dementia>10;

7. Familial AD;

8. Abnormal brain structural magnetic resonance imaging (MRI) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome;

9. Surgical history of the central nervous system;

10. Severe cardiovascular/pulmonary disorders.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• DBS of the fornix, power on
DBS of bilateral columns of the fornix is performed, with the power of the device on since the 1st month after the implantation. Observations will start at the time when the device is turning on . DBS system includes: Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode; Pins E202 DBS extension lead
• DBS of the NbM, power on
DBS of bilateral NbMs is performed, with the power of the device on since the 1st month after the implantation. Observations will start at the time when the device is turning on . DBS system includes: Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode; Pins E202 DBS extension lead
• DBS of the fornix, power off
DBS of bilateral columns of the fornix is performed, the power of the device is going to keep off during the first 7 months after the implantation. Observations will start after 1 month of the implantation. DBS system includes: Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode; Pins E202 DBS extension lead
• DBS of the NbM, power off
DBS of bilateral NbMs is performed, the power of the device is going to keep off during the first 7 months after the implantation. Observations will start after 1 month of the implantation. DBS system includes: Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode; Pins E202 DBS extension lead

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University.	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	Beijing Pins Medical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive outcome	Cognitive function measured by Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 13-items version).; ADAS-cog 13 scale range: 0-80; (Higher value represents a worse outcome)	12 months (from 1 month to 13 month after implantation)
Secondary	Neuroplasticity outcome	Protection of hippocampal volume revealed by magnetic resonance imaging (MRI).	12 months (from 1 month to 13 month after implantation)
Secondary	Neuroplasticity outcome	Improved cerebral metabolic level revealed by FDG positron emission tomography(PET) imaging.	12 months (from 1 month to 13 month after implantation)
Secondary	Cognitive outcome	Improvement of cognitive function evaluated by Clinical Dementia Rating Scale sum of the boxes (CDR-SB).; CDR-SB scale range: 0-18; ("0" represents normal cognition, the higher the score, the worse the cognitive function).	12 months (from 1 month to 13 month after implantation)
Secondary	Functional outcome	Improvement of life quality according to Activities of Daily Living (ADL) scale.; ADL scale range: 20-80 ("20" represents normal life ability, the higher the score, the worse the life ability).	12 months (from 1 month to 13 month after implantation)
Secondary	Safety outcome	Device/therapy related side effects or complications such as mortality an morbidity.	12 months (from 1 month to 13 month after implantation)